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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K000377
Device Name MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
Applicant
Masif Healthcare Products Sdn. Bhd.
Ladang Pinji, Bahagian Sengat,
Kampung Kepayang,
Ipoh, Perak, Darul Ridzuan,  MY 31300
Applicant Contact YEOH SENG GUAN
Correspondent
Masif Healthcare Products Sdn. Bhd.
Ladang Pinji, Bahagian Sengat,
Kampung Kepayang,
Ipoh, Perak, Darul Ridzuan,  MY 31300
Correspondent Contact YEOH SENG GUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/07/2000
Decision Date 06/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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